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Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
FLUOCINONIDE TOPICAL SOLUTION Alcohol content USP36–NF31 3618 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Standard solution: Change
Dilute 20.0 mL of USP Alcohol
to:
Dilute 20.0 mL of alcohol
GADOTERIDOL INJECTION Bacterial endotoxins <85> USP36–NF31 3701 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2: Change
gadoteridol.
to:
Gadoteridol Injection.
GRANISETRON HYDROCHLORIDE INJECTION Assay USP36–NF31 3772 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 10 of Procedure: Change
100(312.41 / 348.87)(C/L)(rU / rS)
to:
100(312.41 / 348.87)(C/CU)(rU / rS)
AND
Line of 14 of Procedure: Change
L is… Read More
KETOROLAC TROMETHAMINE TABLETS IMPURITIES/Organic Impurities USP36–NF31 4042 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Sample solution: Change
Proceed as directed for the Sample stock solution in the Assay.
to:
Proceed as directed for the Sample solution in the Assay.
LEVALBUTEROL INHALATION SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP36–NF31 4080 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 35: Delete
USP Levalbuterol Related Compound H RS
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C14H23NO3 253.34
MINERAL OIL SPECIFIC TESTS USP36–NF31 4372 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Viscosity—Capillary Viscometer Methods <911>: Change
34.5 and 150.0 mm2· s−1
to:
34.5–150.0 mm2· s−1
OCTINOXATE Assay USP36–NF31 4556 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Chromatographic system: Change
a 0.32-mm × 25-m column that contains coating G1,
to:
a 0.32-mm × 25-m column with 0.25-µm thickness of phase G1 coating,
LACTATED RINGER'S INJECTION Definition USP36–NF31 5055 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13: Change
408.0 mg of chloride
to:
428.0 mg of chloride
RISPERIDONE USP Reference standards <11> USP36–NF31 5063 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 7 of USP Risperidone System Suitability Mixture RS: Change
9-Hydroxyrisperidone-(6RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
9-Hydroxyrisperidone: (9RS)-3-{2-[4-(6… Read More
RISPERIDONE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP36–NF31 5067 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9/0.5/0.3/0.3 (area %) mixture of the following four compounds:
Risperidone (98.9%)
Risperidone cis-N-oxide (0.5%): cis-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9… Read More
ATROPINE SULFATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP36–NF31 5948 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Sample solution: Change
0.1 mg/mL in water
to:
0.1 g/mL of Atropine Sulfate in water
ISOTRETINOIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 4 First Supplement to USP36–NF31 6000 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13 of System suitability: Add section heads before "Calculate the percentage....":
Analysis
Samples: Standard solution and Sample solution
BUFFER SOLUTIONS 4. Standard Buffer Solutions/4.1 Preparation Second Supplement to USP36–NF31 6244 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid
CHINESE SALVIA COMPOSITION/Content of Salvianolic Acid B Second Supplement to USP36–NF31 6331 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 16 of Analysis: Change
W = weight of Chinese Salvia used to prepare the Sample solution (mg)
to:
W = weight of Chinese Salvia used to prepare the Sample stock solution (mg)
VALERIAN TINCTURE STRENGTH/Content of Valerenic Acids Second Supplement to USP36–NF31 6352 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
90.0%–120.0%
to:
NLT 0.015% of valerenic acids, calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid
CAPSICUM OLEORESIN SPECIFIC TESTS/Limit of Nonivamide Second Supplement to USP36–NF31 6577 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
on the dried basis
to:
on the anhydrous basis
CYCLOBENZAPRINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP36–NF31 6585 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Cyclobenzaprine Related Compound A RS: Change
5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol.
to:
5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]-cyclohepten-5-ol.
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 5 Second Supplement to USP36–NF31 6592 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Acid stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
AND
Line 3 of Buffer stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
LORATADINE IMPURITIES/Organic Impurities, Procedure 1 Second Supplement to USP36–NF31 6650 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Note: Change
4,8-dichloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
to:
4,8-dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
PARICALCITOL INJECTION IMPURITIES/Organic Impurities/Chromatographic system/Columns Second Supplement to USP36–NF31 6678 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Guard: Change
4.6-mm × 7.5-cm
to:
4.6-mm × 7.5-mm
RISPERIDONE ORAL SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP36–NF31 6690 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9: 0.5: 0.30: 0.3 (area %) mixture of four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-… Read More
TRAMADOL HYDROCHLORIDE ASSAY/Procedure Second Supplement to USP36–NF31 6715 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of System suitability solution: Change
USP Tramadol Hydrochloride Related Compound A RS
to:
USP Tramadol Related Compound A RS
<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Options for Demonstrating Compliance USP36–NF31 151 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 17 of Summation Option: Change
the manufacturer must validate
to:
the manufacturer must ensure
<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING USP36–NF31 151 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
If, by validated processes and supply-chain control,
to:
If, by process monitoring and supply-chain control,
ACETYLTRIBUTYL CITRATE IDENTIFICATION/B. USP36–NF31 1869 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
USP Acetyltriethyl Citrate RS
to:
USP Acetyltributyl Citrate RS
DILUTED ALCOHOL ADDITIONAL REQUIREMENTS USP36–NF31 1874 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Delete USP Reference Standards <11> section
BEHENOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol/Titrimetric system USP36–NF31 1892 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode: Change
Direct titration
to:
Residual titration
BETADEX IMPURITIES/Limit of Reducing Sugars USP36–NF31 1905 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 3 of Tartrate solution: Change
20 mg/mL of anhydrous sodium sulfate
to:
200 mg/mL of anhydrous sodium sulfate
CAPRYLOCAPROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 1922 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VT − VB)
to:
(VB − VS)
AND… Read More
CETOSTEARYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 1954 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 16 of Analysis: Change
Result = [(VS − VB) × F]/W
to:
Result = [(VB… Read More
CETYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP36–NF31 1956 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 9 of Analysis: Change
Result = [(VS − VB) × F]/W
to:
Result = [(VB… Read More
EGG PHOSPHOLIPIDS ASSAY/Content of Phospholipids USP36–NF31 2000 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2 of Solution A: Change
acetic acid
to:
glacial acetic acid
AND
Line 2 of Solution B: Change
acetic acid
to:
glacial acetic acid
ETHYL OLEATE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2006 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Change:
and
to:
or
FERROSOFERRIC OXIDE IMPURITIES USP36–NF31 2018 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample solution C in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution D in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line… Read More
GLYCERYL MONOLINOLEATE ASSAY/Procedure USP36–NF31 2030 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 13 of Chromatographic system: Change
Column temperature: 40°
to:
Temperatures
Detector: 40°
Column: 40°
HYDROXYETHYL CELLULOSE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2038 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
LAUROYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2064 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
LINOLEOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2068 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
OLEOYL POLYOXYLGLYCERIDES IMPURITIES/Limit of Free Glycerol USP36–NF31 2112 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(VS − VB)
to:
(VB − VS)
AND
Line 11 of Analysis:… Read More
POLYISOBUTYLENE IMPURITIES/Lead <251> USP36–NF31 2149 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
NMT 3 mg/g
to:
NMT 3 μg/g
POLYOXYL 10 OLEYL ETHER SPECIFIC TESTS/Average Polymer Length USP36–NF31 2150 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 9 of Analysis: Change
Result = [(31 A2/A1 − 3)]/4
to:
Result = [(31 × A2/A1) − 3]/4
POLYOXYL 20 CETOSTEARYL ETHER SPECIFIC TESTS/Average Polymer Length USP36–NF31 2155 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 16 of Analysis: Change
Result = [32 × A2/(A1 − 3)]/4
to:
Result = [(32 × A2/A1) − 3]/4
POLYSORBATE 80 SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2163 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
POTASSIUM METAPHOSPHATE SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> USP36–NF31 2172 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1: Change
and
to:
or
SORBITAN MONOLAURATE IDENTIFICATION/A. USP36–NF31 2212 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
260–280
to:
260–280 on 1-g sample
SORBITAN MONOOLEATE IDENTIFICATION/A. USP36–NF31 2213 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample
SORBITAN MONOPALMITATE IDENTIFICATION/A. USP36–NF31 2213 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
210–225
to:
210–225 on 1-g sample
SORBITAN MONOSTEARATE IDENTIFICATION/A. USP36–NF31 2214 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
200–215
to:
200–215 on 1-g sample
SORBITAN SESQUIOLEATE IDENTIFICATION/A. USP36–NF31 2215 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample
SORBITAN TRIOLEATE IDENTIFICATION/A. USP36–NF31 2216 27-Sep-2013 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 1 of Sample: Change
1 g of the residue of oleic acid obtained in the Assay for Fatty Acids
to:
Residue obtained in the Assay for Fatty Acids
AND
Line 2 of Acceptance criteria: Change
192–204
to:
192–204 on 1-g sample